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路透社

美国卫生部门批准移除三款雌二醇透皮贴剂的“黑框警告”US health department to remove broad black box warning from three estrogen patch products

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2020年8月29日,美国马里兰州白橡树,美国食品药品监督管理局总部外可见标识。路透社/安德鲁·凯利/资料照片Signage is seen outside of the Food and Drug Administration headquarters in White Oak, Maryland, U.S., August 29, 2020. REUTERS/Andrew Kelly/File Photo

美国卫生部门周五批准从三款雌二醇透皮贴剂标签上移除最严格的“黑框警告”,这些激素疗法用于治疗更年期症状。

The US health department on Friday approved the removal of the strictest "black box" warnings from the labels of three estradiol transdermal patches, the hormone therapies used to treat menopause symptoms.

由于需求激增,美国女性一直难以找到雌激素贴剂等激素替代疗法来缓解情绪波动、潮热和睡眠障碍等症状。

Women in the United States have been struggling to find hormone replacement treatments such as estrogen patches to ease symptoms, including mood swings, hot flashes and sleep disturbances, amid surging demand.

美国卫生与公众服务部未立即回应路透社关于贴剂品牌名称的置评请求。

The US Department of Health and Human Services did not immediately respond to a Reuters request seeking brand names for the patches.

此举是在FDA(美国食品药品监督管理局)2月批准对六款更年期激素疗法产品进行标签变更、移除与心血管疾病、乳腺癌和可能的痴呆相关的警告之后采取的。FDA自9月以来一直在与制造商合作以增加雌激素贴剂供应,但尚未将贴剂指定为短缺药品。

“过去一年雌激素贴剂市场产量翻了一番,制造商仍在继续扩大产能,”国家儿童健康与人类发展研究所副所长多萝西·芬克在媒体电话会上表示。

The action adds to labeling changes to six menopausal hormone therapy products that the FDA in February approved to remove warnings related to cardiovascular disease, breast cancer and probable dementia The US Food and Drug Administration has been working with manufacturers since September to boost supplies of estrogen patches, but has not designated the patches as being in shortage "Estrogen patch market output has doubled over the past year, and manufacturers continue to expand capacity," said Dorothy Fink, deputy director of the National Institute of Child Health and Human Development, on a media call FDA is working expeditiously with applicants to take action on labeling changes for the remaining menopausal hormone therapy products "FDA has expedited the review and approval of 10 supplements this year to date, which are requests from manufacturers to make changes that could expand production.

“FDA正在加快与申请人的合作,对剩余更年期激素疗法产品的标签变更采取行动,”FDA药物评价与研究中心监管项目副主任莎拉·易卜拉欣说,“截至今年,FDA已加快审批了10份补充申请,这些是制造商为做出可能扩大生产的变更而提出的请求。仅在过去一周内,就有两份请求获批。”

路透社此前曾报道,一些注射用和阴道用雌激素产品也处于短缺状态。

Two of these requests were approved within the past week alone," said Sarah Ibrahim, deputy center director for regulatory programs at FDA's Center for Drug Evaluation and Research Reuters had previously reported that some injectable and vaginal estrogen products were also in short supply

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